Phoenix Bioengineering, Inc.
United StatesFDA applicant, unverified
- Devices
- 3
What Phoenix Bioengineering, Inc. makes
Phoenix Bioengineering, Inc. manufactures the Sexton Cystotomy Urine Pump (SCUP2), a device for managing urinary drainage in surgical procedures, as well as Phoenix Bone Screws (PBS-Type Series) for orthopedic fixation. The company also produces burr hole buttons, such as the Burr 1, used in neurosurgical applications for securing implants or drainage systems.
The company’s portfolio consists of Class II medical devices, all of which are subject to FDA 510(k) clearance requirements. These devices are listed under the FDA’s regulatory framework, and the company is headquartered in the United States.
Catalogue
Sexton Cystotomy Urine Pump (SCUP2) Ref K904434
Regimes: 510(k) Registry: 510(k)Phoenix Bone Screws Pbs-Type Series Ref K930125
Regimes: 510(k) Registry: 510(k)Phoenix Burr Hole Button, Burr 1 Ref K913490
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Phoenix Bioengineering, Inc. have in the registry?
The registry currently lists 3 devices for Phoenix Bioengineering, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Phoenix Bioengineering, Inc.'s devices?
Among its 3 most recently registered devices, Phoenix Bioengineering, Inc. has devices listed in FDA 510(k) (3 devices).
What risk classes do Phoenix Bioengineering, Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Phoenix Bioengineering, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Phoenix Bioengineering, Inc. in the registry?
The most recently registered devices listed for Phoenix Bioengineering, Inc. include SEXTON CYSTOTOMY URINE PUMP (SCUP2), PHOENIX BONE SCREWS PBS-TYPE SERIES and PHOENIX BURR HOLE BUTTON, BURR 1.